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FDA 510(k)

BIO-CHALLENGE TEST PAK

K-Number: K851804 · 1985-07-16

ApplicantPropper Mfg. Co., Inc.
Decision Date1985-07-16
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BIO-CHALLENGE TEST PAK is the device name listed in this FDA 510(k) record. The listed applicant is Propper Mfg. Co., Inc.. It received FDA 510(k) clearance on 1985-07-16 under 510(k) number K851804. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-CHALLENGE TEST PAK?

BIO-CHALLENGE TEST PAK is a medical device that received FDA 510(k) clearance on 1985-07-16. The listed applicant is Propper Mfg. Co., Inc.. The 510(k) number is K851804.

When did BIO-CHALLENGE TEST PAK receive FDA 510(k) clearance?

BIO-CHALLENGE TEST PAK received FDA 510(k) clearance on 1985-07-16, under 510(k) number K851804.

Who is the listed applicant for BIO-CHALLENGE TEST PAK?

The FDA 510(k) record lists Propper Mfg. Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIO-CHALLENGE TEST PAK?

The FDA product code for BIO-CHALLENGE TEST PAK is JOJ.

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Other records listing Propper Mfg. Co., Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K111453STEAM DOT BLU PROCESS INDICATORK102894CLASSIX CHEMICAL STERILIZATION INDICATORK082620ONCE-A-DAY VERTOS TEST PACKK031152PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST)K991618BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATORK991276PASS/FAIL CHALLENGE PACK

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Related Devices (Code: JOJ)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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